BillionToOne’s Northstar Select Chosen as Lead Liquid Biopsy in Major Japanese NSCLC Resistance Study

New updates have been reported about BillionToOne.

BillionToOne has secured a strategic clinical foothold in Japan after its Northstar Select liquid biopsy was selected as the primary genomic testing platform for LC-SCRUM-TRY, a nationwide, multi-center study focused on treatment-resistant non-small cell lung cancer (NSCLC). Led by the National Cancer Center Hospital East and involving more than 100 institutions, the study has already evaluated around 2,000 cases of advanced or recurrent NSCLC post–drug resistance, and is now shifting from mainly tissue-based biopsies to plasma-based cell-free DNA analysis to overcome challenges of tumor accessibility, sample insufficiency, and patient reluctance toward invasive procedures. Beginning November 2025, Northstar Select will be used as the preferred assay for comprehensive genomic profiling, positioning BillionToOne at the core of efforts to characterize resistance mechanisms and guide future therapy development in this patient population.

The selection follows comparative evaluations in which investigators determined that broader adoption of liquid biopsy in this setting required materially higher sensitivity than a previously used assay, especially for detecting rare or low-frequency variants. Northstar Select, built on BillionToOne’s single-molecule NGS platform and proprietary QCT technology, has demonstrated superior sensitivity in peer-reviewed, head-to-head prospective data, detecting SNVs and indels at variant allele frequencies down to 0.15% and outperforming other commercial assays for therapy selection. The test also meets Medicare MolDx coverage criteria in the U.S., supporting its clinical and economic validation. For BillionToOne, this collaboration with NCCHE expands its international clinical footprint, strengthens the real-world evidence base for Northstar Select in advanced oncology, and may enhance future reimbursement, adoption, and partnership opportunities as precision medicine for drug-resistant cancers continues to gain priority among global healthcare systems.